Adolescent Idiopathic Scoliosis (AIS)NCT07574229
Support System Design for Adolescent Scoliosis Orthosis Wear
A study testing Digital Support System for AIS Orthosis Wear in people with Adolescent Idiopathic Scoliosis (AIS) and Adherence, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study focuses on improving the daily lives and treatment outcomes of teenagers diagnosed with Adolescent Idiopathic Scoliosis (AIS). For many young patients, wearing a corrective brace for 20+ hours a day is physically uncomfortable and psychologically challenging, leading to low compliance and emotional… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS), Adherence
- What is being tested?
- Digital Support System for AIS Orthosis Wear
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of Adolescent Idiopathic Scoliosis (AIS).
- Current orthotic treatment with a prescription for a spinal brace (e.g., Boston, Milwaukee, or similar corrective braces).
- Between 10 and 18 years of age at the time of enrollment.
- Ability to read, understand, and complete the Intrinsic Motivation Inventory (IMI) and other study-related questionnaires.
- Access to a stable home environment with Wi-Fi or local network connectivity for the interactive desktop terminal.
- Willingness of the participant to provide assent and the legal guardian to provide written informed consent.
Who cannot join
- Secondary scoliosis caused by neuromuscular, congenital, or syndromic conditions (e.g., cerebral palsy or Marfan syndrome).
- Scheduled spinal surgery within the planned study period.
- Severe skin allergies or chronic dermatological conditions at the brace contact sites that might be aggravated by sensor integration.
- Previous participation in similar digital intervention studies for scoliosis management.
- Diagnosed cognitive impairments or severe psychological disorders that may interfere with accurate reporting or regular use of the product system.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200140
Zhao Liu, 18801971294, hotlz@sjtu.edu.cn
About this study
Official title: A Product System Intervention Study on Improving Wear Compliance and Psychological Motivation for Adolescent Idiopathic Scoliosis Patients Based on Sensory Monitoring and Interactive Feedback
This study focuses on improving the daily lives and treatment outcomes of teenagers diagnosed with Adolescent Idiopathic Scoliosis (AIS). For many young patients, wearing a corrective brace for 20+ hours a day is physically uncomfortable and psychologically challenging, leading to low compliance and emotional distress.The investigators have developed an integrated "Product System" designed to transform the bracing experience from a burdensome task into a guided, supportive journey. This system consists of three main components:Smart Sensing: Discrete, thin-film pressure sensors are integrated into the existing brace to monitor real-time wear time and fit quality without compromising comfort.Interactive Desktop Terminal: A dedicated device for the home that uses "narrative-driven" feedback (themed around a journey called "The Spine's Path"). Instead of cold medical data, it provides intuitive progress visualizations and rewards to keep participants engaged.Mobile Support App: A tool for both participants and parents to track long-term trends, access educational resources, and facilitate communication with healthcare providers.The Goal of the Study The primary objective is to evaluate how this digital intervention affects a participant's "Intrinsic Motivation"-the internal drive to adhere to treatment. By focusing on three psychological dimensions-Interest/Enjoyment, Perceived Competence, and Pressure/Tension-the investigators aim to determine if interactive feedback can reduce the "medical feel" of the brace and help teenagers feel more in control of the recovery.What Participation Involves Participants will use the product system during the daily routine in home and school environments. The investigators will collect objective data (brace usage hours) and subjective data (through the Intrinsic Motivation Inventory/IMI scale) to measure changes in behavior and mental well-being.Benefits for Families and ProvidersFor Participants: A more engaging, less stressful way to manage the condition and see real-time progress.For Families: Reduced friction regarding brace-wearing and better visibility into the participant's treatment status.For Healthcare Providers: Access to accurate, objective data on participant compliance, allowing for more personalized and effective clinical adjustments.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS), Adherence
- Being tested
- Digital Support System for AIS Orthosis Wear, Conventional Treatment Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Support System for AIS Orthosis WearDevice
Smart Monitoring: Thin-film pressure sensors integrated into the brace to automatically record daily wear time and pressure distribution.
Interactive Terminal: A desktop device for the home that converts sensor data into "narrative-driven" feedback (e.g., "The Spine's Path") with rewards.
Mobile App: A tool for patients and parents to track long-term trends, access educational content, and facilitate family interaction.
Psychological Assessment: Participants will periodically complete the Intrinsic Motivation Inventory (IMI) to evaluate the system's impact on interest, competence, and pressure reduction.
Conventional Treatment Control GroupBehavioural
Standard Care: Participants wear their conventional spinal braces according to their physician's prescription without any electronic monitoring or feedback devices.
Manual Logging: Adherence data (daily wear time) is recorded manually by patients or parents through paper diaries or self-reporting during follow-ups.
Routine Clinical Support: Participants receive standard medical education and attend scheduled physical examinations and adjustments.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Product System Intervention Arm | Experimental | Participants in this arm will use an integrated digital support system consisting of:
Smart Monitoring: Thin-film pressure sensors integrated into the brace to automatically record daily wear time and pressure distribution.
Interactive Terminal: A desktop device for the home that converts sensor data into "narrative-driven" feedback with rewards.
Mobile App: A tool for patients and parents to track long-term trends, access educational content, and facilitate family interaction.
Psychological Assessment: Participants will periodically complete the Intrinsic Motivation Inventory (IMI) to evaluate the system's impact on interest, competence, and pressure reduction. Receives: Device: Digital Support System for AIS Orthosis Wear |
| Conventional Treatment Control Group | Sham comparator | Standard Care: Participants wear their conventional spinal braces according to their physician's prescription without any electronic monitoring or feedback devices.
Manual Logging: Adherence data (daily wear time) is recorded manually by patients or parents through paper diaries or self-reporting during follow-ups.
Routine Clinical Support: Participants receive standard medical education and attend scheduled physical examinations and adjustments. Receives: Behavioral: Conventional Treatment Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthosis Wearing Compliance (Brace Adherence)
The average daily wear time of the scoliosis brace, automatically recorded by the integrated pressure sensors. Compliance is calculated as the percentage of actual wear time versus the physician-recommended duration.
Measured: 4 weeks
Intrinsic Motivation Score (IMI)
Changes in the patient's intrinsic motivation levels as measured by the Intrinsic Motivation Inventory (IMI). This includes three specific sub-scales: Interest/Enjoyment, Perceived Competence, and Pressure/Tension (using a 7-point Likert scale).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Feb 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Reasoning: While your project involves a device and behavioral intervention, its primary goal is to evaluate and improve the delivery of care-specifically, how to enhance treatment adherence (compliance) and the psychological experience of adolescent patients undergoing long-term orthopedic therapy.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Dian, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhao Liu, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574229
- Sponsor's protocol ID
- NEADS006
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to ensure the privacy and confidentiality of the minor participants. Data access is restricted to the primary research team for the purposes of the specified study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Product System Intervention Study on Improving Wear Compliance and Psychological Motivation for Adolescent Idiopathic Scoliosis Patients Based on Sensory Monitoring and Interactive Feedback
- ClinicalTrials.gov ID
- NCT07574229
- Acronym / sponsor ID
- NEADS006
- Conditions
- Adolescent Idiopathic Scoliosis (AIS), Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study focuses on improving the daily lives and treatment outcomes of teenagers diagnosed with Adolescent Idiopathic Scoliosis (AIS). For many young patients, wearing a corrective brace for 20+ hours a day is physically uncomfortable and psychologically challenging, leading to low compliance and emotional distress.The investigators have developed an integrated "Product System" designed to transform the bracing experience from a burdensome task into a guided, supportive journey. This system consists of three main components:Smart Sensing: Discrete, thin-film pressure sensors are integrated into the existing brace to monitor real-time wear time and fit quality without compromising comfort.Interactive Desktop Terminal: A dedicated device for the home that uses "narrative-driven" feedback (themed around a journey called "The Spine's Path"). Instead of cold medical data, it provides intuitive progress visualizations and rewards to keep participants engaged.Mobile Support App: A tool for both participants and parents to track long-term trends, access educational resources, and facilitate communication with healthcare providers.The Goal of the Study The primary objective is to evaluate how this digital intervention affects a participant's "Intrinsic Motivation"-the internal drive to adhere to treatment. By focusing on three psychological dimensions-Interest/Enjoyment, Perceived Competence, and Pressure/Tension-the investigators aim to determine if interactive feedback can reduce the "medical feel" of the brace and help teenagers feel more in control of the recovery.What Participation Involves Participants will use the product system during the daily routine in home and school environments. The investigators will collect objective data (brace usage hours) and subjective data (through the Intrinsic Motivation Inventory/IMI scale) to measure changes in behavior and mental well-being.Benefits for Families and ProvidersFor Participants: A more engaging, less stressful way to manage the condition and see real-time progress.For Families: Reduced friction regarding brace-wearing and better visibility into the participant's treatment status.For Healthcare Providers: Access to accurate, objective data on participant compliance, allowing for more personalized and effective clinical adjustments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Reasoning: While your project involves a device and behavioral intervention, its primary goal is to evaluate and improve the delivery of care-specifically, how to enhance treatment adherence (compliance) and the psychological experience of adolescent patients undergoing long-term orthopedic therapy.
| Arm | Type | Receives |
|---|---|---|
| Integrated Product System Intervention Arm | Experimental | Device: Digital Support System for AIS Orthosis WearParticipants in this arm will use an integrated digital support system consisting of: Smart Monitoring: Thin-film pressure sensors integrated into the brace to automatically record daily wear time and pressure distribution. Interactive Terminal: A desktop device for the home that converts sensor data into "narrative-driven" feedback with rewards. Mobile App: A tool for patients and parents to track long-term trends, access educational content, and facilitate family interaction. Psychological Assessment: Participants will periodically complete the Intrinsic Motivation Inventory (IMI) to evaluate the system's impact on interest, competence, and pressure reduction. |
| Conventional Treatment Control Group | Sham comparator | Behavioral: Conventional Treatment Control GroupStandard Care: Participants wear their conventional spinal braces according to their physician's prescription without any electronic monitoring or feedback devices. Manual Logging: Adherence data (daily wear time) is recorded manually by patients or parents through paper diaries or self-reporting during follow-ups. Routine Clinical Support: Participants receive standard medical education and attend scheduled physical examinations and adjustments. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of Adolescent Idiopathic Scoliosis (AIS).
- Current orthotic treatment with a prescription for a spinal brace (e.g., Boston, Milwaukee, or similar corrective braces).
- Between 10 and 18 years of age at the time of enrollment.
- Ability to read, understand, and complete the Intrinsic Motivation Inventory (IMI) and other study-related questionnaires.
- Access to a stable home environment with Wi-Fi or local network connectivity for the interactive desktop terminal.
Key exclusion criteria (5 listed)
- Secondary scoliosis caused by neuromuscular, congenital, or syndromic conditions (e.g., cerebral palsy or Marfan syndrome).
- Scheduled spinal surgery within the planned study period.
- Severe skin allergies or chronic dermatological conditions at the brace contact sites that might be aggravated by sensor integration.
- Previous participation in similar digital intervention studies for scoliosis management.
- Diagnosed cognitive impairments or severe psychological disorders that may interfere with accurate reporting or regular use of the product system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Support System for AIS Orthosis WearSmart Monitoring: Thin-film pressure sensors integrated into the brace to automatically record daily wear time and pressure distribution. Interactive Terminal: A desktop device for the home that converts sensor data into "narrative-driven" feedback (e.g., "The Spine's Path") with rewards. Mobile App: A tool for patients and parents to track long-term trends, access educational content, and facilitate family interaction. Psychological Assessment: Participants will periodically complete the Intrinsic Motivation Inventory (IMI) to evaluate the system's impact on interest, competence, and pressure reduction. | Device | Integrated Product System Intervention Arm |
| Conventional Treatment Control GroupStandard Care: Participants wear their conventional spinal braces according to their physician's prescription without any electronic monitoring or feedback devices. Manual Logging: Adherence data (daily wear time) is recorded manually by patients or parents through paper diaries or self-reporting during follow-ups. Routine Clinical Support: Participants receive standard medical education and attend scheduled physical examinations and adjustments. | Behavioural | Conventional Treatment Control Group |
Primary outcome
Orthosis Wearing Compliance (Brace Adherence)
Time frame: 4 weeks
The average daily wear time of the scoliosis brace, automatically recorded by the integrated pressure sensors. Compliance is calculated as the percentage of actual wear time versus the physician-recommended duration.
Intrinsic Motivation Score (IMI)
Time frame: 4 weeks
Changes in the patient's intrinsic motivation levels as measured by the Intrinsic Motivation Inventory (IMI). This includes three specific sub-scales: Interest/Enjoyment, Perceived Competence, and Pressure/Tension (using a 7-point Likert scale).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to ensure the privacy and confidentiality of the minor participants. Data access is restricted to the primary research team for the purposes of the specified study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhao Liu principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Support System for AIS Orthosis Wear in people with Adolescent Idiopathic Scoliosis (AIS) and Adherence, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dian Zhu, Dr (+8618901626266, zhudian@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthosis Wearing Compliance (Brace Adherence) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.